Zdrowie i gospodarka · 30/10/2007
Draft Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Acute Bacterial Sinusitis: Developing Drugs for Treatment." The purpose of this guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drug products for the treatment of acute bacterial sinusitis (ABS). The agency's thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of our current thinking in this area. In addition, it will fulfill a statutory requirement to publish such a guidance enacted in the Food and Drug Administration Amendments Act of 2007 (FDAAA).